Details for New Drug Application (NDA): 215279
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NDA 215279 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Barr, Chartwell Rx, Hikma Pharms, Impax Labs, and Novitium Pharma, and is included in five NDAs. It is available from twelve suppliers. Additional details are available on the FLUDROCORTISONE ACETATE profile page.
The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.
The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.
Summary for 215279
| Tradename: | FLUDROCORTISONE ACETATE |
| Applicant: | Novitium Pharma |
| Ingredient: | fludrocortisone acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215279
Suppliers and Packaging for NDA: 215279
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 215279 | ANDA | Major Pharmaceuticals | 0904-7317 | 0904-7317-06 | 50 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACK |
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 215279 | ANDA | Major Pharmaceuticals | 0904-7317 | 0904-7317-61 | 100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | May 31, 2022 | TE: | AB | RLD: | No | ||||
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